Geneoscopy, Inc.: Medical Device Recall in 2025 - (Recall #: Z-2077-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

ColoSense Test Kit, Part No. 80-001, component of ColoSense test

Product Classification:

Class II

Date Initiated: May 20, 2025

Date Posted: July 9, 2025

Recall Number: Z-2077-2025

Event ID: 97017

Reason for Recall:

Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.

Status: Ongoing

Product Quantity: 10 units

Code Information:

Lot number 80-001-A2501

Distribution Pattern:

US Nationwide distribution in the state of Missouri.

Voluntary or Mandated:

Voluntary: Firm initiated